The term of an Australian pharmaceutical patent may be extended if a product covered by the claims receives regulatory approval in Australia. An extension of the term of a patent can be worth literally hundreds of millions of dollars to the patentee. Consequently, this is an area of Australian patent law that is of significant commercial interest.

The patent term extension (PTE) provisions were introduced to compensate for the loss of “effective” pharmaceutical patent life due to

(a) lengthy drug development periods, and

(b) the need to obtain regulatory approval which delays entry of the product onto the market. Accordingly, an Australian patent may be eligible for an extension of term if more than 5 years elapses between the date of filing of the patent and the date of first inclusion on the Australian Register of Therapeutic Goods (ARTG) of goods containing or consisting of the patented pharmaceutical substance.

Importantly, an application for a PTE must be lodged within six months from the later of the following dates:

a) the date the patent was granted

b) the date of first inclusion in the ARTG of a pharmaceutical substance covered by the patent.

In the event that a PTE application is not filed by the relevant deadline, it is possible to request an extension of time, under Section 223, in which to perform an “act” when the “act” was not carried out at the appropriate time due to an error or omission on the part of the applicant or their attorney. Given the potential value of the PTE, it may be well worth pursuing an extension of time in which to make the appropriate request.

A recent Australian Patent Office decision, Mount Sinai School of Medicine [2013] APO 52 (5 September 2013) considered an application for an extension of time for the purpose of extending the period for filing a PTE application. The period of extension sought was 9 years and 11 months, from 17 November 2002 to 17 October 2012.

The patent-in-suit, AU691795, in the name of Mount Sinai School of Medicine (MSSM) and licensed exclusively to Genzyme Corporation (Genzyme), is directed to methods of producing α-galactosidase A (REPLAGAL/FABRAZYME). It is due to expire on 30 November 2013.

In the decision it was indicated that the potential PTE based on the date of the patent (30 November 1993) and the date of first inclusion on the ARTG of the product REPLAGAL (17 May 2002), is the maximum period of five years. However, this appears to be an error. The term of a PTE, according to s77 of Patents Act 1990, is equal to the period from the date of the patent to the earliest regulatory approval date, less five years. In the present case this period is 3 years, 5 months and 17 days.

Evidence

The evidence submitted by MSSM attempted to persuade the Deputy Commissioner of Patents that the failure to file a PTE application occurred as a result of an error or omission within s223 and that absent the error or omission, a PTE application would have been filed for the Australian patent prior to the relevant deadline.

Initially, MSSM submitted declaratory evidence that they relied, in 2002, on the licensee (in the present case, Genzyme) to inform them of the status of regulatory approval of any pharmaceutical products covered by a patent. When notification of marketing authorisation of the product in a particular country was received this would “initiate the decision making process for whether or not to extend the patent”.

However in a second declaration MSSM stated, contrary to the first declaration, that they did not have a general practice in relation to PTEs in November 2002 and that this was developed subsequently. Rather, MSSM relied on the responsible attorneys in different jurisdictions to provide advice in relation to the relevant laws and procedures for their patents. In this regard, a declaration prepared by the Australian attorneys responsible for the prosecution of the patent (Phillips Ormonde Fitzpatrick (POF)) states that they did not in any correspondence prior to April 2012 state that the patent may qualify for an extension of term.

Thus, the evidence submitted appears to suggest that either one of two errors resulted in the failure to file the application for PTE namely, the failure of Genzyme to inform MSSM about the status of the relevant regulatory approval and/or the failure of the Australian attorneys to provide advice regarding the eligibility of the patent for a PTE. The extension of the equivalent US patent was put forward as being indicative of MSSM’s likely intention to extend the Australian patent.

Findings

The Deputy Commissioner of Patents found that while an error or omission may have occurred, the evidence did not address the circumstances that existed at the relevant time in a full and frank manner. This suggested a significant possibility that MSSM only recently determined that an extension of term was desirable and that there was no real intention to extend the patent before the relevant date.

In relation to the alleged error that Genzyme had failed to inform MSSM of the ARTG listing for FABRAZYME, the Deputy Commissioner of Patents found that the evidence indicated that Genzyme had no such obligation and that the trigger in Australia was in fact the listing of REPLAGAL not FABRAZYME.

Regarding the failure of the Australian attorneys, Phillips Ormonde and Fitzpatrick (POF), to provide advice about a possible PTE, the Deputy Commissioner of Patents stated that until the listing of REPLAGAL in 2002, an extension of time could not have been requested. Thus, it was considered that the failure of POF to provide relevant advice regarding PTE would only be significant if the advice would have prompted MSSM to put in place processes for monitoring the ARTG for the inclusion of goods containing α-galactosidase A. However, the Deputy Commissioner of Patents found that there was insufficient evidence to conclude that such advice would have made a difference to MSSM’s actions.

The Deputy Commissioner of Patents also found that the evidence and surrounding circumstances did not show a “demonstrated desire” to obtain an extension of term in Australia. The obtaining of an extension for the equivalent US patent was considered to be suggestive that a decision to seek extension may have been made but it was also considered that there might have been reasons why the decision would have been different, such as the different commercial value of FABRAZYME in Australia. In this regard, evidence detailing the specific importance of obtaining a term extension in Australia was not provided.

Ultimately, it was considered that significant unanswered doubts existed that MSSM, in the relevant period, intended to obtain a PTE in Australia and failed to do so due to an error or omission. On this basis the application for an extension of time to file the PTE was refused.

The extension of time application was also refused on discretionary grounds because it was found that the patentee and its agents had unreasonably protracted the uncertainty concerning the term of the patent close to the end of its term.

Concluding comments

The above Patent Office decision highlights the importance for vigilance in relation to patent applications and patents claiming subject matter that potentially falls within the eligibility criteria for a PTE.

In order to obtain a PTE, the patent must relate to a pharmaceutical substance per se or a pharmaceutical substance when produced by recombinant DNA technology. The pharmaceutical substance must be disclosed in the specification and must fall within the scope of the claims.

It is notable that the claims for AU691795 are directed to methods of producing α-galactosidase A. There are no claims directed to α-galactosidase A per se. Therefore, even in the event that the extension of time to file a PTE was granted by the Patent Office, MSSM may have experienced difficulty having the PTE granted for lack of a claim directed to a pharmaceutical substance per se.

Under Australian law, product-by-process claims are permitted and as the methods defined in AU691795 relate to recombinant DNA technology, it would have been prudent to include relevant product-by-process claim(s) during prosecution of the application.

To ensure that the critical PTE deadlines are not overlooked, Shelston IP offers a service whereby a written reminder is issued on a 6-monthly basis starting from the date of grant of the patent. If you would like to avail of this reminder service, or require further information about obtaining a PTE, please let us know.

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